Varicose vein dissector and removal apparatus

ABSTRACT

A varicose vein dissector and removal apparatus includes a handle having a first end and a second end, a dissector extending from the first end of the handle and a hook extending from the second end of the handle, and a blade positioned within the dissector for movement between a use position and a storage position. The apparatus is used by creating an initial incision in skin over a varicose vein to be removed, advancing the dissector into the incision and dissecting around the varicose vein to be removed, pushing the dissector against an inner surface of the skin a predetermined distance from the initial incision, exposing the blade by moving it from its storage position to its use position and creating a second incision in the skin letting the dissector protrude out of the skin, and grasping the vein with the hook and removing the vein.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 11/884,200, entitled “VARICOSE VEIN DISSECTOR AND REMOVALAPPARATUS”, filed Aug. 13, 2007, which issued as U.S. Pat. No.8,034,070, which is the National Stage of International Application No.PCT/US2006/006425, filed Feb. 24, 2006, entitled AVARICOSE VEINDISSECTOR AND REMOVAL APPARATUS@, which claims the benefit of U.S.Provisional Patent Application Ser. No. 60/656,573, filed Feb. 25, 2005,entitled “VARICOSE VEIN DISSECTOR AND REMOVAL APPARATUS”.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a varicose vein dissector and removalapparatus. The present invention is also directed to a method forvaricose vein removal utilizing the present apparatus.

2. Description of the Prior Art

Ten to fifteen percent of the population suffers from varicose veins.These veins have usually lost their ability to carry blood back to theheart and blood often accumulates in these veins. As a result, the veinsmay become swollen, distorted, and prominent. Inefficient or defectiveone-way valves that prevent blood from draining back through the veinusually cause this condition. Varicose veins may cause patients toexperience various symptoms including aching, burning, swelling,cramping and itching. More serious complications of varicose veins caninclude thrombophlebitis, dermatitis, hemorrhage and ulcers. Manypatients seek medical treatment of varicose veins for cosmetic reasons.

Several treatment options exist for the treatment of varicose veins. Oneoption is sclerotherapy. In sclerotherapy, the affected veins areinjected with a sclerosing solution. The sclerosing solution causesinflammation and sclerosis of the veins. The sclerosis results inlocalized scarring or closure of the veins. There are severalcomplications associated with sclerotherapy including staining of theskin, ulcers, skin ischemia, necrosis and neuropathy.

Another procedure for treatment of varicose veins is ambulatoryphlebectomy (also knows as stab phlebectomy or microphelebectomy). Inthis technique, incisions are made in the skin of the patient, and ahook is inserted into the incision to grip or hook the veins to beremoved. When the veins are grabbed, the veins are gently pulled throughthe surgical incision and severed. This procedure usually requires anassistant to the surgeon and can take up to 1-2 hours in some cases.This procedure also usually requires multiple incisions in order to hookthe affected veins. It is often difficult to completely remove theentire affected veins.

More particularly, the current technique for performing ambulatoryphlebectomy is as follows: a small incision (1-2 mm) is made in the skinover the vein; the vein is dissected from its surrounding tissue(optional); a hook is used to grab the vein through the small incisionand pull the vein partly out of the skin; a clamp is used to gently andmeticulously pull the vein out of the skin (the vein usually severs atthe skin after several centimeters of vein have been removed); andanother incision is made several centimeters away and the process isrepeated.

As described above, traditional ambulatory phlebectomy is performedusing individual small punctures or incisions over superficial varicoseveins followed by grasping of the veins and teasing them out of theskin. Included among the drawbacks to this technique are that the amountof vein removed is sometimes small, the veins are pulled and torn easilycausing bleeding and hematoma, many punctures or incisions are oftenrequired, the procedure is time consuming, and there are often areas ofvein that are not removed.

As those skilled in the art will certainly appreciate, a need exists foran improved technique for performing ambulatory phlebectomy, as well asimproved surgical apparatuses. The present invention provides both animproved surgical technique and an associate surgical apparatus.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide avaricose vein dissector and removal apparatus. The apparatus includes ahandle having a first end and a second end, a dissector extending fromthe first end of the handle and a hook extending from the second end ofthe handle, and a blade positioned within the dissector for movementbetween a use position and a storage position.

It is also an object of the present invention to provide an apparatuswherein the handle, hook and dissector are made from a stiff plasticmaterial or metal.

It is another object of the present invention to provide an apparatuswherein the dissector is substantially flat.

It is a further object of the present invention to provide an apparatuswherein the dissector includes parallel upper and lower surfaces.

It is also another object of the present invention to provide anapparatus wherein the dissector has a length of approximately 5 cm toapproximately 7 cm.

It is yet another object of the present invention to provide anapparatus wherein the dissector has a width of approximately 3 mm and athickness of slightly over 1 mm.

It is also a further object of the present invention to provide anapparatus wherein the dissector includes a free end from which the bladeis selectively extended when moved between a use position and a storageposition.

It is still a further object of the present invention to provide anapparatus wherein a button is coupled to the blade facilitating movementbetween a use position and storage position.

It is also an object of the present invention to provide an apparatuswherein the button extends up through a slot formed in the handle.

It is another object of the present invention to provide an apparatuswherein the hook is substantially U-shaped.

It is a further object of the present invention to provide an apparatuswherein the hook is approximately 2 mm to approximately 5 mm indiameter.

It is also an object of the present invention to provide a method forambulatory phlebectomy employing the present varicose vein dissector andremoval apparatus. The method is achieved by creating an initialincision in skin over a varicose vein to be removed, advancing thedissector into the incision and dissecting around the varicose vein tobe removed, pushing the dissector against an inner surface of the skin apredetermined distance from the initial incision, exposing the blade bymoving it from its storage position to its use position and creating asecond incision in the skin letting the dissector protrude out of theskin, and grasping the vein with the hook and removing the vein.

It is another object of the present invention to provide a methodwherein the step of pushing is performed several centimeters from theinitial incision.

It is still a further object of the present invention to provide anapparatus including the step of repeating the steps of advancing,pushing and exposing along the length of the varicose vein.

Other objects and advantages of the present invention will becomeapparent from the following detailed description when viewed inconjunction with the accompanying drawings, which set forth certainembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of the present a varicose vein dissector andremoval apparatus with the internal components shown in phantom and theblade in its storage positioned.

FIG. 2 is a top plan view of the present apparatus with the blade in itsuse position.

FIG. 2A is a cross sectional view along the line A-A in FIG. 2.

FIGS. 3 to 8 show the steps associated with the use of the presentapparatus in performing ambulatory phlebectomy.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The detailed embodiments of the present invention are disclosed herein.It should be understood, however, that the disclosed embodiments aremerely exemplary of the invention, which may be embodied in variousforms. Therefore, the details disclosed herein are not to be interpretedas limiting, but merely as the basis for the claims and as a basis forteaching one skilled in the art how to make and/or use the invention.

With reference to the various figures, a varicose vein dissector andremoval apparatus 10 for performing an ambulatory phlebectomy isdisclosed. Briefly, the present apparatus 10 includes an elongated stiffcomponent, that is, a dissector 12, connected to a handle 14. A blade 16is positioned within the dissector 12 for selective movement between ause position extending from the dissector 12 and a storage positionhidden within the dissector 12. The blade 16 is connected to a button 18extending from the handle 14 for ready actuation by a user to move theblade 16 between its storage position and its use position. After thedissection of a varicose vein in a manner discussed below in greaterdetail, the blade 16 is pushed forward to its use position using thebutton 18 and the blade 16 is forced through the skin creating anincision in the skin from the inside out. The back end of the apparatus10 includes a hook 20 shaped and dimensioned for grasping of the veinand pulling of the vein out through the skin. With the foregoing in mindand as will be appreciated based upon the following detailed disclosure,an operator will have control over the activation of the presentapparatus 10 and the timing of the blade 16 exposure.

More particularly, the present apparatus 10 includes a centrallypositioned handle 14 having a first end 22 and a second end 24. Adissector 12 extends from the first end 22 of the handle 14 and a hook20 extends from the second end 24 of the handle 14. In accordance with apreferred embodiment, the handle 14, hook 20 and dissector 12 are madefrom a stiff plastic material or metal. The present apparatus 10 must bestiff enough to dissect tissue but the edges of it should be blunt toprevent damage to the veins during dissection.

As will be appreciated based upon the following disclosure, thedissector 12 is shaped and dimensioned for passage through an initialsmall incision made in the skin measuring anywhere from 1 mm to 5 mm,dissection around a varicosity and placement against the internalsurface of the skin several centimeters from the initial incision. Inaccordance with a preferred embodiment, the dissector 12 issubstantially flat including parallel upper and lower surfaces 26, 27with a rounded edge 28 connecting the upper and lower surfaces 26, 27.With this in mind, the dissector 12 has a length of approximately 5 cmto approximately 7 cm. The dissector 12 preferably has a width ofapproximately 3 mm and a thickness of slightly over 1 mm. In fact, thedissector 12 has a width that is less than a width of the handle 14 (seeFIGS. 1 and 2). Although the dissector is flat in shape in accordancewith a preferred embodiment of the present invention, the dissector maybe constructed with a variety of cross sectional profiles withoutdeparting from the spirit of the present invention.

The dissector 12 is provided with a free end 30 from which the blade 16is selectively extended for creating additional incisions in accordancewith the present invention. More particularly, the dissector 12 isprovided with a central passage 32 in which the blade 16 is stored. Aswill be appreciated further based upon the following disclosure of theprocedure in accordance with the present invention, the small blade 16is stored within the dissector 12 for reasons of safety and preventionof damage to the tissues and varicosities during dissection. Inaccordance with a preferred embodiment, the blade 16 is shaped anddimensioned to extend about a millimeter from the free end 30 of thedissector 12 when moved to its use position. In accordance with apreferred embodiment of the present invention, the portion of the blade16 extending from the free end 30 of the dissector 12 is shaped like astandard blade with one side sharp or shaped like an arrow with sharpedges on both sides. As those skilled in the art will appreciate,various blade designs could be used without departing form the spirit ofthe present invention.

The rear end 34 of the blade 16 is coupled to an actuator 36 extendingback through the dissector 12 to a button 18 that extends up through thehandle 14 for actuation by the user. As such, a physician using thepresent apparatus 10 may readily actuate the button 18 to move the blade16 from its storage position within the dissector 12 to its use positionextending beyond the free end 30 of the dissector 12. With this in mind,the handle 14 is provided with a longitudinal slot 38 from which thebutton 18 extends. The slot 38 allows one to move the button 18 (andultimately the actuator 36 and blade 16) forward and backward between ause position and a storage position.

As briefly mentioned above, a hook 20 extends from the second end 24 ofthe handle 14. The hook 20 is substantially U-shaped for grasping andretrieving veins as discussed below. In accordance with a preferredembodiment the hook 20 is approximately 2 mm to approximately 5 mm indiameter, depending upon the size of vein to be removed (bigger hooksare used for bigger veins). With this in mind, the present apparatuswill be made with hooks of various sizes to be used in accommodating theneeds of specific patient conditions.

The present apparatus 10 employs a modified phlebectomy technique inwhich dissection with a long dissector along the entire length of thevaricosity 100 is performed prior to vein extraction (See FIGS. 3 to 8).After the initial puncture or incision 102 is made in the area of thevaricose vein 100, the subsequent incisions 104, 106, 108 are made withthe present apparatus 10, in particular, the dissector 12 and blade 16,several centimeters from the previous puncture site (See FIGS. 5, 6, 7and 8).

As those skilled in the art will certainly appreciate, the termspuncture and, incision are generally interchangeable for the purposes ofdescribing an ambulatory phlebectomy. Specifically, some operators use aneedle to make the initial skin incision, in which case it is more apuncture hole, while others use a surgical blade, in which case it ismore an incision. Since most physicians use a surgical blade, the termincision is predominantly used throughout the present disclosure,although those skilled in the art will appreciate that puncturescertainly fall within the spirit of the present invention.

The incisions 102, 104, 106, 108 are formed repeatedly along the wholelength of the varicosity 100. The dissector 12 can be inserted throughone of the incision sites 102, 104, 106, 108 and the dissectionprocedure can be continued. After dissection and the creation of aseries of incisions 102, 104, 106, 108 along the varicosity 100, thevein 110 is grasped using the hook 20 extending from the second end 24of the present apparatus 10 and removed easily. The amount of vein 110removed and the cosmetic results after vein removal using the presentcontinuous phlebectomy technique are superior to traditionalphlebectomy.

More particularly, an initial small incision (1-2 mm) 102 is made in theskin 112 over the vein 110 to be removed, the dissector 12 is advancedinto the incision 102 and dissection around the varicosity 100 isperformed (FIG. 3). The dissector 12 is pushed against the inner surface114 of the skin 112 several centimeters from the initial incision 102(FIG. 4) and the blade 16 is exposed by moving the button 18 forwardsuch that the blade 16 is moved from its storage position to its useposition (FIG. 5). This creates an incision 104 in the skin 112 and letsthe dissector 12 protrude out of the skin 112 (FIG. 6). The blade 16 inthe dissector 12 is then withdrawn back to its storage position withinthe dissector 12 and the dissector 12 is withdrawn from the initialincision 102. The dissector 12 is then advanced into the newly formedincision site and the process is repeated creating additional incisions106, 108 and dissecting the vein 110 (FIG. 7). After all the varicosity100 has been dissected, the hook 20 of the apparatus 10 is used to graspthe vein 110 and remove it (FIG. 8).

The present apparatus offers a variety of advantages. In particular, itprovides enhanced efficiency as longer segments of vein will be pulledthrough each incision and the procedure time will, therefore, bereduced. The present device also offers improved safety by decreasingthe number of required incisions, thereby reducing infection risk. Thedevice further decreases the risk to the operator because the incisionis made with the dissection device and not with an exposed blade. Thepresent device is also cost-effective in that procedure time is reducedand the device is disposable (also providing reduced risk of infectionto the patient).

While the preferred embodiments have been shown and described, it willbe understood that there is no intent to limit the invention by suchdisclosure, but rather, is intended to cover all modifications andalternate constructions falling within the spirit and scope of theinvention.

The invention claimed is:
 1. A varicose vein dissector and removalapparatus, comprising: a handle including a first end and a second end;a dissector extending from the first end of the handle and a hookextending from the second end of the handle, the dissector includes acentral passage and has a length of approximately 5 cm to approximately7 cm, and the dissector has a width that is less than a width of thehandle; a blade positioned within the central passage of the dissectorfor movement between a use position where the blade is extended from afree end of the dissector and a storage position where the blade isstored within the central passage, a rear end of the blade is coupled toan actuator extending back through the central passage of the dissectorto a button that extends up through a slot formed in the handle foractuation by the user.
 2. The apparatus according to claim 1, whereinthe handle, hook and dissector are made from a stiff plastic material ormetal.
 3. The apparatus according to claim 1, wherein the dissector issubstantially flat.
 4. The apparatus according to claim 3, wherein thedissector includes parallel upper and lower surfaces.
 5. The apparatusaccording to claim 3, wherein the dissector has a width of approximately3 mm and a thickness of slightly over 1 mm.
 6. The apparatus accordingto claim 3, wherein the dissector includes a free end from which theblade is selectively extended when moved between a use position and astorage position.
 7. The apparatus according to claim 1, wherein thedissector has a width of approximately 3 mm and a thickness of slightlyover 1 mm.
 8. The apparatus according to claim 1, wherein the dissectorincludes a free end from which the blade is selectively extended whenmoved between a use position and a storage position.
 9. The apparatusaccording to claim 1, wherein the hook is substantially U-shaped. 10.The apparatus according to claim 9, wherein the hook is approximately 2mm to approximately 5 mm in diameter.
 11. The apparatus according toclaim 10, wherein the dissector is substantially flat.
 12. The apparatusaccording to claim 11, wherein the dissector includes parallel upper andlower surfaces.